Technology-driven Solutions

PVConsult™

Optimise your PV operations through monitoring and use of technology by our SMEs.

PVTransition™

Come to rescue of your PV systems during service provider modifications or technology switch.

PVBridge™

Help our long-standing clients to develop in-house pharmacovigilance capacity.

PVIntegrate™

Streamline your PV systems and processes during expansion.

PVExpert™

Strengthen your negotiations with regulators, HTAs and external stakeholders.

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Services

End-to-End Pharmacovigilance Services

Benefit-Risk Management

Case Processing

Safety Systems and Reporting

QPPV and PSMF

Local Contact Person for Pharmacovigilance

GVP Audits/Inspection Preparedness

Medical Information Services

Safety and Medical Writing

Literature Surveillance

Signal Management

Pharmacoepidemiology

Medical Monitoring

Clinical Trial Safety Committee Management

Safety Management Plan

Project Management

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Product Expertise

Innovative/Brand Products

Pharmacovigilance expertise to support the development of risk minimisation measures pre-, peri- and post-marketing, complex ICSR management and an evaluation strategy of Innovative/Brand portfolio.

Generics, Hybrids, Biosimilars

Methodical management of challenging pharmacovigilance agreements (SDEAs), signal detection, audits schedules & conduct and training for Generics, Hybrids and Biosimilars.

Vaccines

A comprehensive pharmacovigilance management of seasonal Vaccines ICSRs and systems, well-positioned to coordinate end-to-end PV activities of your immunisation portfolio.

Devices and Combination Products

Our vigilance and pharmacovigilance experts can advise you on the complex regulatory prerequisites that characterise PV activities related to medical devices and combination products.

Pediatric Medicines

We never underestimate the importance of performing tailored PV research in pediatrics and draw lessons from risk minimisation of ARs in adult population.

Medicines for Older People

We adjust or co-develop your risk management plans cognizant that co-morbidities or side effects, which are specific to older patients, may shape your post-authorisation PV activities.

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